Philips Respironics, Inc. medical device recall: Philips Respironics Trilogy Evo
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98540
- Recall initiated
- Mar 2, 2026
- Classified by FDA
- Apr 2, 2026
- Posted in Enforcement Report
- Apr 8, 2026
- Recalling firm
- Philips Respironics, Inc.
- Firm location
- Murrysville, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Mar 2, 2026. FDA classified it 31 days later, on Apr 2, 2026. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel,… Philips Respironics, Inc. has 27 recalls in our records.
Recalled products (4)
Z-1646-2026 Class I Ongoing
Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.
Codes / lots: All Model No.; All UDI; All Serial No.
Quantity: 113,717 units
Z-1647-2026 Class I Ongoing
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
Codes / lots: All Model No.; All UDI; All Serial No.
Quantity: 113,717 units
Z-1648-2026 Class I Ongoing
Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.
Codes / lots: All Model No.; All UDI; All Serial No.
Quantity: 113,717 units
Z-1649-2026 Class I Ongoing
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Codes / lots: All Model No.; All UDI; All Serial No.
Quantity: 113,717 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98540
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.